NeoLead Mini N300

GUDID 10812594011747

Electrode (Box of 20)

NEOTECH PRODUCTS, INC.

Electrocardiographic electrode, single-use
Primary Device ID10812594011747
NIH Device Record Key3dac375e-bb3c-4eb1-acc0-c34e13911a43
Commercial Distribution StatusIn Commercial Distribution
Brand NameNeoLead Mini
Version Model Number10812594011747
Catalog NumberN300
Company DUNS198013435
Company NameNEOTECH PRODUCTS, INC.
Device Count50
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numbertrue
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100812594011627 [Unit of Use]
GS110812594011747 [Primary]

FDA Product Code

DRXElectrode, Electrocardiograph

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2021-06-14
Device Publish Date2016-09-14

On-Brand Devices [NeoLead Mini]

00812594011740812594011740
10812594011747Electrode (Box of 20)

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